Evaluating Onyx™ Liquid Embolic System for treating active arterial bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Onyx™ Liquid Embolic System in patients experiencing active arterial bleeding in the peripheral vasculature, which excludes the heart and brain. It is a pivotal, prospective, multi-center, non-randomized, single-arm study enrolling up to 135 subjects across 25 sites in the United States. Participants will undergo the embolization procedure and will have follow-up visits at hospital discharge and 30 days post-procedure to monitor outcomes and any need for reintervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is ≥ 22 years old.
2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.

   In this study, peripheral vasculature is defined as outside the brain and heart.
3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
5. Target treatment area is free from prior embolization treatment.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Symptoms of active infection.
3. Patient is known to be participating in the study of an investigational drug, biologic, or device.
4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
5. Known allergy to components of Onyx™.
6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

Where it's running

• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford Medical Center
  Palo Alto, California, United States Recruiting
• UCHealth University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Yale New Haven
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Osman Ahmed, MD — University of Chicago
• Study coordinator: Janki Shah
• Email: janki.shah@medtronic.com
• Phone: 7322662503

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.